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Monday, August 10, 2009

Those HIV serodiscordant couples' studies...

There has been some evidence that if guys are circumcised they're less likely to pick up HIV (and possibly other STIs) from people they happen to have unsafe sex with. Some clever public health folks wanted to know whether that cuts also the other way round, ie whether HIV infected men are less likely to transmit the bug when they're circumcised. What better place to investigate such speculations than Africa.

The medical journal THE LANCET just published a piece testing just this hypothesis. The investigators recruited 922 uncircumcised HIV infected men whose female partners happened to be still HIV negative. They then circumcised half of the guys. The women were informed of the objective of the study, but - as far as I can see - it was left open whether the male partner was HIV infected or not. This was so, because in addition to the infected guys they also had non-infected guys in the study, but obviously they were not 'counted' as there was nothing these guys could have passed on to their partners anyhow. So the women had no certainty to assume that their partner was HIV infected (as opposed to the next woman's partner). Indeed, the study authors concede that 'Inclusion of only couples who agreed before enrolment to couples' counselling and result disclosure [sic!] might have resulted in lower HIV transmission rates in both trial groups.' (p.236)

The investigators jumped otherwise thru the usual ethics loops, there's informed consent, folks were counselled to use condoms and that safe sex is imperative. To give them credit where credit is due: anyone who seroconverted during the study (ie who became infected) will be supplied with life-preserving AIDS medication when that is clinically indicated. So, HIV negative women who seroconverted during the study will be offered chemotherapy.

I've got to be honest: I do not believe such studies ought to take place. For starters, there was truly no good reason to assume that circumcision would have any impact whatsoever on transmission rates - and, surprise, surprise, it had no impact. Still, epidemiologists do what epidemiologists do best, they watch and report. So, in our case we had medical professionals who knew that there were a large number of HIV infected men whose partners did not positively know of their infection - the study authors confirm this for a quarter of each group. They then stood idly by and watched what happened. Turns out that circumcision doesn't reduce HIV transmission rates.

I can't get my head around the idea that the medical researchers should have had no moral obligations to warn the women in this study of the HIV infection of their partner. Now, you'll object that that would defeat the purpose of this study. You are right, but it would reduce the incidence of HIV infection and premature death among the women in question. You'll say that that would also prevent the investigators from undertaking this study. Exactly, that is why I think such research should not take place.

We know already what prevents HIV transmission. Put infected people on AIDS medicines (HAART) and drop all the social science investigative nonsense. You'll say that for us to do that we need more cash and more people tested. You're right on both counts. A good start could have been not to waste money on such research then and use the cash where it demonstrably would do some good.

Is it just me, or are there other people who get the idea that "research" these days is either of a nonsensical nature, or - as in the case under review - borders on the criminal? It's really all about the grant money, isn't it, and to hell with the victims.(Clara Wiekhorst)

Udo, You are of course right that this study was ethically unacceptable, and indeed that the money spent on the study could have been put to far better use.

But to throw out all studies (clinical, social science, epidemiology, whatever) might be a bit hasty. We have effective ways of treating HIV and limiting infection, but they are not perfect (as far as I can tell). While we should certainly invest in making these current treatments available, we should also try to develop better solutions. But the point remains: our efforts to do so ought to be designed to produce real clinical benefits and - just as importantly - be far more ethically scrupulous than the study in question.